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Status unknownNCT04718272Updated May 11, 2021

Safety and Feasibility of the Application of Thoracic Puncture Tube After Pulmonary Lobectomy

An interventional study of thoracic drainage management in Chest Tubes, Pneumonectomy and Minimally Invasive Surgery, sponsored by Fujian Medical University Union Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by Fujian Medical University Union Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.

Read the detailed description

This study will be accepted in patients with uniportal VATS(Video-assisted Thoracoscopic Surgery)lobetomy. A randomized controlled study protocol will be used, and The patients will be devided into two groups: experimental group for the application of a small thoracic puncture tube and control group for the application of Combination of the puncture tube and traditional silicone tube. The intraoperative conditions, postoperative recovery and the incidence of perioperative complications will be compared. The safety and feasibility of the application of the small thoracic puncture tube after pulmonary lobectomy will be evaluated.

02

Conditions studied

  • Chest Tubes
  • Pneumonectomy
  • Minimally Invasive Surgery

Keywords

  • Chest Tubes
  • Pneumonectomy
  • Minimally Invasive Surgery
03

In context

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age and gender: 18-70 years old, male and female unlimited;
  2. Cardiopulmonary function can tolerate operation;
  3. Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed;
  4. No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position.
  5. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..

Exclusion criteria

Exclusion Criteria:

  1. Patients with a severe emphysema or pulmonary bullae;
  2. Patients with a history of chemotherapy or chemo-radiotherapy;
  3. Patients with a history of chest surgery;
  4. Extensive thoracic adhesion ;
  5. A history of serious mental illness;
  6. Patients with other conditions considered by the researcher should not participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Puncture tube group

    After the operation, the traditional traditional silicone tube which placed through the surgical incision was removed in the operating room, and the small puncture tube was retained for thoracic drainage.

    Procedure: thoracic drainage management

  • No intervention
    Traditional tubes group

    Routine thoracic drainage management measures were adopted, that is, both of the small puncture tube and traditional silicone tube were retained after surgery.

Interventions

  • Procedurethoracic drainage management

    After uniportal VATS pulmonary lobectomy, the traditional silicone tube which placed through the surgical incision was removed in the operating room in the experimental group.

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative complications

    The incidence of complications within 30 days after surgery in each arm

    Time frame: within 30 days after surgery

Secondary outcomes

  1. Incidence of subcutaneous emphysema after operation

    The incidence of subcutaneous emphysema after operation in each arm

    Time frame: within 30 days after surgery

  2. Incidence of postoperative pneumothorax

    The incidence of postoperative pneumothorax in each arm

    Time frame: within 30 days after surgery

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04718272
Lead sponsor
Fujian Medical University Union Hospital
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Jan 25, 2021
Primary completion
Apr 30, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
May 11, 2021

Study contacts

Guobing Xu, MD
Contact
15880005394@163.com
15880005394
Chun Chen, MD
Contact
chenchun0209@163.com
13365910325
Chun Chen, MD
study director · Fujian Medical University Union Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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